CE Marking for Medical Devices [Step-by-Step Guide] 如何获得 CE 认证

如何获得 CE 认证

Foreword 前言

To sell and market your medical device across the European Union (EU), you must have a CE marking of conformity.

要在欧洲联盟（EU）范围内销售和推广您的医疗设备，您必须获得符合 CE 标志。

Manufacturers of medical and in vitro diagnostic devices that wish to be part of the European Economic Area market must adhere to regulatory requirements to ensure their products meet quality and safety standards.

希望成为欧洲经济区市场一部分的医疗和体外诊断设备制造商必须遵守监管要求，以确保其产品符合质量和安全标准。

Legislation and international standards regarding medical devices, such as EU MDR 2017/745 and ISO 13485:2016, can be complex to follow but is essential to life science organizations’ success. Not following these regulations and standards can lead to manufacturers stopping their production altogether.

关于医疗设备的立法和国际标准，如 EU MDR 2017/745 和 ISO 13485:2016，可能很复杂，但对于生命科学组织的成功至关重要。不遵守这些法规和标准可能导致制造商完全停止生产。

In this article, we will learn about the principal regulations for obtaining CE marking, followed by a step-by-step guide to getting a medical device’s CE marking. We will also visit some of the most common questions regarding this matter and see how an Electronic Quality Management System (eQMS) can help you streamline the process to have a declaration of conformity.

在本文中，我们将了解获得 CE 标志的主要法规，然后逐步指南获取医疗设备的 CE 标志。我们还将回答一些关于此事的常见问题，并看看电子质量管理系统（eQMS）如何帮助您简化流程以获得符合性声明。

One of the best ways to streamline your processes to obtain a CE marking nowadays is to use eQMS software. SimplerQMS offers a cloud-based eQMS for medical devices that supports regulatory compliance, audit process, document control, all the technical documentation you will need, and much more. Book a demo with one of our quality solution experts and be a step closer to your CE marking!

现在，简化流程以获得 CE 标志的最佳方法之一是使用 eQMS 软件。SimplerQMS 为医疗设备提供基于云的 eQMS，支持监管合规性、审计流程、文件控制、所有所需的技术文件等等。与我们的质量解决方案专家预约演示，离您的 CE 标志更近一步！

What Is CE Marking for Medical Devices? 医疗器械的 CE 标志是什么意思？

CE marking means Conformité Européenne or European conformity in French. And as the name suggests, it proves product compliance with European requirements that ensure specific safety, health, and environmental protection standards.

CE 标志是法语中的 Conformité Européenne 或欧洲合规的意思。正如其名称所示，它证明产品符合欧洲要求，确保特定的安全、健康和环境保护标准。

It can be required for several different products. Regarding medical devices, the CE marking allows companies to move and sell their devices across the 30 countries of the European Economic Area (EEA) once they follow the EU Regulation 2017/746, also known as Medical Device Regulation (MDR).

它可能适用于多种不同的产品。关于医疗器械，CE 标志允许公司在遵循欧盟法规 2017/746（也称为医疗器械法规）后，在欧洲经济区（EEA）的 30 个国家之间移动和销售其设备。

The MDR is the European regulation concerning placing medical devices and accessories on the market for human use.

MDR 是关于将医疗器械和配件投放市场供人类使用的欧洲法规。

Another similar legislation is EU 2017/746 for in vitro diagnostic devices, referred to as In Vitro Diagnostic Regulation or IVDR. However, IVDR is not the aim of this article.

另一项类似的法规是 EU 2017/746，适用于体外诊断器械，称为体外诊断法规或 IVDR。然而，IVDR 不是本文的目的。

So, to summarize, the letters ‘CE’ on medical devices represents a product that meets all legal requirements to be traded throughout the EEA. Manufacturers know their devices can be sold and marketed legally, and patients benefit from a safe device.

因此，总结一下，医疗器械上的字母“CE”代表符合所有法律要求，可以在 EEA 范围内进行交易的产品。制造商知道他们的设备

Why Is CE Marking Important? 为什么 CE 标志很重要？

All medical devices that comply with European legislation can obtain a CE marking.

符合欧洲法规的所有医疗器械都可以获得 CE 标志。

A product cannot be legally sold and marketed in EEA countries without it. Devices used exclusively for research are the only exception and can enter these countries.

没有 CE 标志，产品在欧洲经济区国家是不能合法销售和推广的。仅用于研究的设备是唯一的例外，可以进入这些国家。

Complying with this regulation brings opportunities for many companies worldwide to expand their business.

遵守这一规定为全球许多公司扩大业务带来了机会。

CE marking indicates that the medical device went through risk assessment processes and is a safe and high-quality product for the patient.

CE 标志表示医疗器械经过风险评估过程，是一种安全和高质量的产品，适用于患者。

For instance, during the COVID-19 pandemic, lots of infrared thermometers were placed on the European market. Regardless of the manufacturer’s country of origin, the CE marking indicates that these devices comply with requirements and can be legally sold and marketed in the EEA countries.

例如，在 COVID-19 大流行期间，许多红外线体温计被放置在欧洲市场上。无论制造商的原产国是哪个，CE 标志表示这些设备符合要求，可以在欧洲经济区国家合法销售和推广。

Let’s see some of the key benefits of having a CE marking:

让我们看一下拥有 CE 标志的一些关键好处：

• Indicates that your device complies with essential EU legal requirements. 表示您的设备符合欧盟法律要求。
• Allows commercialization in all 30 member countries of the EEA. 允许在欧洲经济区的所有 30 个成员国进行商业化。
• Some countries outside EEA accept CE marking, which is an advantage when entering other new markets. 一些欧洲经济区以外的国家接受 CE 标志，这是进入其他新市场的优势。
• Indicates your device meets safety and quality regulations and standards. 表示您的设备符合安全和质量法规和标准。

An essential step for obtaining a CE marking is to implement a Quality Management System (QMS). Implementing a medical device eQMS software is a smart decision that has been helping several manufacturers to comply with the MDR and IVDR.

获得 CE 标志的一个重要步骤是实施质量管理体系（QMS）。实施医疗设备 eQMS 软件是一个明智的决策，已经帮助多家制造商符合 MDR 和 IVDR 的要求。

Over the last decade, an increasing number of companies of all sizes have been migrating from paper-based or hybrid QMS systems to specific QMS software solutions.

在过去的十年里，越来越多的各种规模的公司从纸质或混合型 QMS 系统迁移到特定的 QMS 软件解决方案。

SimplerQMS is one such solution, providing an end-to-end quality management software that helps medical device and other Life Science companies streamline their quality processes, speed up time to market, and improve compliance with international standards and regulations such as ISO 13485 and MDR.

SimplerQMS 就是这样一种解决方案，提供了一种端到端的质量管理软件，帮助医疗设备和其他生命科学公司简化其质量流程，加快上市时间，并提高符合国际标准和法规（如 ISO 13485 和 MDR）的能力。

Relevant Standards and Regulations 相关标准和法规

It is essential to know the regulations and standards involved in medical devices. We will break down the most important international standards and regulations you need to know to understand better how the CE marking process works.

了解医疗设备涉及的法规和标准是至关重要的。我们将详细介绍您需要了解的最重要的国际标准和法规，以更好地了解 CE 标志流程的工作原理。

Regulation (EU) 2017/745 aka MDR

The regulation EU 2017/745, also referred to as the Medical Devices Regulation or MDR, is the current regulation that replaces the previous Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD) entirely.

法规 EU 2017/745，也称为医疗器械法规或 MDR，是当前取代以前的医疗器械指令（MDD）和主动植入式医疗器械指令（AIMD）的法规。

The regulation describes all the mandatory procedures, transition arrangements, and explanations. If you are a medical device manufacturer, please always refer to this regulation for accurate information.

该法规描述了所有强制性程序、过渡安排和解释。如果您是医疗器械制造商，请始终参考该法规以获取准确的信息。

Although it was published in 2017, the requirements for placing medical devices on the European market only took effect on 26 May 2021.

尽管它是在 2017 年出版的，但将医疗器械放置在欧洲市场上的要求直到 2021 年 5 月 26 日才生效。

According to MDR, transition arrangements allow some devices already on the market with MDD to remain available until 27 May 2025.

根据 MDR，过渡安排允许一些已经在市场上的 MDD 设备保持可用，直到 2025 年 5 月 27 日。

However, as we write this article, the European Commission proposes a deadline extension postponing the MDR deadline of 26 May 2024 until 2027 for Class III and IIb devices and May 2028 for Class IIa and I devices.

然而，正如我们撰写本文时，欧洲委员会提议延长截止日期，对于 III 类和 IIb 类设备，将 2024 年 5 月 26 日的 MDR 截止日期延迟到 2027 年，以及 对于 IIa 类和 I 类设备延迟至 2028 年 5 月。

Directive 2001/83/EC

Directive 2001/83/EC is related to placing medicinal products for human use on the market.

指令 2001/83/EC 与将人用药品投放市场有关。

When medical devices are combined with a medicinal product, such as a drug, manufacturers need to determine which part of the combined product is responsible for its main activity.

当医疗器械与药品（如药物）结合时，制造商需要确定组合产品的哪个部分负责其主要活动。

If the drug helps improve the medical device’s activity and cannot be used alone, it becomes an integral part of the device. The combined product is considered a medical device and must be in accordance with EU 2017/745.

如果药物有助于改善医疗器械的活动并且不能单独使用，则它成为设备的组成部分。组合产品被视为医疗器械，必须符合 EU 2017/745。

Regulation (EC) 276/2004

Regulation EC 276/2004 is related to placing medicinal products for humans and veterinary use on the market.

法规 EC 276/2004 与将人用药品和兽医用药品投放市场有关。

Regarding medical devices, it works the same way as Directive 2001/83/EC.

关于医疗器械，它与指令 2001/83/EC 的工作方式相同。

Directive 2004/23/EC

The directive 2004/23/EC sets quality and safety standards for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells.

指令 2004/23/EC 为人体组织和细胞的捐赠、采购、测试、加工、保存、储存和分发设定了质量和安全标准。

Medical devices containing non-viable tissues or cells with a secondary activity must comply with MDR.

含有非活性组织或细胞的医疗器械必须符合 MDR 的要求。

EU MDR’s general safety and performance requirements must apply to the part of the device containing those elements, regardless of their main activity.

无论其主要活动如何，欧盟 MDR 的一般安全和性能要求必须适用于含有这些元素的设备的部分。

ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes 医疗器械 — 质量管理体系 — 法规目的要求

The ISO 13485:2016 standard outlines the requirements of a QMS for medical devices.

ISO 13485:2016 标准概述了医疗器械质量管理体系的要求。

Manufacturers of medical devices usually adhere to this standard since following it presumes compliance with QMS requirements presented in the MDR.

医疗器械制造商通常遵循此标准，因为遵循该标准意味着符合 MDR 中提出的质量管理体系要求。

Following this standard indicates compliance with QMS requirements, such as:

遵循此标准表示符合质量管理体系要求，例如：

• Quality Manual 质量手册
• Document and Record control 文件和记录控制
• Quality management system 质量管理体系
• Human resources 人力资源
• Manufacturers infrastructure 制造商基础设施
• Contamination control 污染控制
• Design and development planning, verification, validation, transfer, changes, and files of medical devices 医疗器械的设计和开发计划、验证、验证、转移、变更和文件
• Evaluation and selection of suppliers 供应商的评估和选择
• Servicing activities 维修活动
• Requirements for sterile medical devices 无菌医疗器械的要求
• Identification and traceability of medical devices 医疗器械的识别和追溯性
• Complaint handling 投诉处理
• Control of nonconforming products 不合格产品的控制
• Post-market surveillance 市场后监测

ISO 14971:2019 Medical devices — Application of risk management to medical devices 医疗器械 — 对医疗器械应用风险管理

ISO 14971:2019 was developed specifically for medical device manufacturers based on established risk management principles and can be used as guidance in developing and maintaining processes.

ISO 14971:2019 是专门为医疗器械制造商开发的，基于已建立的风险管理原则，并可用作开发和维护流程的指导。

Risk management is a requirement of MDR. However, manufacturers can achieve compliance without the need to be certified by this ISO.

风险管理是 MDR 的要求。然而，制造商可以在不需要通过此 ISO 认证的情况下实现合规。

FDA 21 CRF Part 820

The FDA 21 CRF Part 820 establishes quality system requirements applicable to medical device manufacturers. It is the current regulation of QMS for medical devices used in the United States.

FDA 21 CRF 第 820 部分建立了适用于医疗器械制造商的质量体系要求。这是美国使用的医疗器械质量管理体系（QMS）的当前法规。

Medical device companies targeting the US market must have a QMS compliant with FDA 21 CFR Part 820 and FDA clearance.

针对美国市场的医疗器械公司必须具备符合 FDA 21 CFR 第 820 部分和 FDA 许可的 QMS。

This code of regulation can serve as a guideline for the QMS requirement of MDR in the European market. However, most companies choose to follow ISO 13485:2016 standard, since it can be certified.

这一法规可以作为欧洲市场 MDR 质量管理体系要求的指南。然而，大多数公司选择遵循 ISO 13485:2016 标准，因为它可以获得认证。

How To Obtain CE Marking for Medical Devices? 如何获得医疗器械的 CE 标志？

Obtaining a CE marking can be rather complex, so to assist you, this guide will outline the general steps of this process.

获得 CE 标志可能相当复杂，因此为了帮助您，本指南将概述此过程的一般步骤。

Keep in mind that this guide is for educational purposes. For complete information, medical device manufacturers should always refer to the MDR.

请记住，本指南仅供教育目的。对于完整的信息，医疗器械制造商应始终参考 MDR。

Many companies hire consulting firms to manage CE marking processes in parts or whole. However, due to the recent MDR implementation, these professionals are in high demand, so it can be difficult to get a hold of them.

许多公司雇用咨询公司来管理部分或全部的 CE 标志流程。然而，由于最近 MDR 的实施，这些专业人员需求量很大，因此很难联系到他们。

The process of placing a medical device on the market generates a high volume of documents. An eQMS can help manufacturers manage all this data accurately, facilitating compliance with QMS requirements in MDR.

将医疗器械投放市场的过程会产生大量文件。电子质量管理系统（eQMS）可以帮助制造商准确管理所有这些数据，促进符合 MDR 的质量管理体系要求。

To ensure documentation is already being created following requirements, having a Medical Device Quality Management System in place is a good start.

为了确保按照要求已经创建了文档，建立一个医疗器械质量管理体系是一个良好的起点。

SimplerQMS supports compliance with all the requirements mentioned above by providing a fully validated eQMS that helps companies manage quality throughout the product life cycle. In the following sections, we will showcase a few more examples of how an eQMS can help streamline some of the processes needed to obtain a CE marking.

SimplerQMS 通过提供一个完全验证的电子质量管理体系来支持符合上述所有要求，帮助企业在产品生命周期中管理质量。在接下来的章节中，我们将展示一些更多的例子，说明电子质量管理体系如何帮助简化一些需要获得 CE 标志的流程。

Note

The general steps of the CE marking are outlined in no particular order.

获得 CE 认证的一般步骤没有特定的顺序。

1. Determine Your Medical Device Classification 确定您的医疗器械分类

The MDR established rules to classify medical devices according to the risk level, placement on the body, and duration of use.

MDR 根据风险级别、身体部位和使用时间等规定了医疗器械的分类。

We will cover them briefly in this article, but you can read our medical device classification guide for more detailed information.

我们将在本文中简要介绍它们，但您可以阅读我们的医疗器械分类指南以获取更详细的信息。

Risk 风险

Devices are divided into classes I, IIa, IIb, and III.

设备分为 I 类、IIa 类、IIb 类和 III 类。

The higher the classification, the higher the risk the device represents to the patient.

分类越高，设备对患者的风险越高。

Body Placement 放置位置

Devices can be non-invasive when they are on the body’s surface and invasive when they penetrate inside the body.

当设备位于身体表面时，可以是非侵入性的；当设备穿透身体内部时，可以是侵入性的。

There are also active devices that depend on a source of energy other than that generated by the human body.

还有一些依赖于人体以外的能源的主动设备。

For example, an X-ray machine, patient monitor, and hearing aid are non-invasive class II devices placed on the body’s surface that are also active since they do not depend on the human body as a source of energy.

例如，X 射线机、病人监护仪和助听器是非侵入性的 II 类设备，它们放置在身体表面上，也是主动设备，因为它们不依赖人体作为能源来源。

On the other hand, a pacemaker is an invasive and active class III device because it needs to be placed inside the body to fulfill its purpose.

另一方面，起搏器是侵入性和主动的 III 类设备，因为它需要放置在体内以实现其目的。

Duration of Use 使用时长

The duration of use is also gradual, being a transient use of up to 60 minutes, a short-term use of up to 30 days, and above that period, it becomes a long-term use device.

使用时长也是逐渐的，短暂使用时间最长为 60 分钟，短期使用时间最长为 30 天，超过这个时间段，它就成为长期使用设备。

The regulation also brings 22 rules to help manufacturers correctly classify their devices. Those rules specify the class of a device based on its application and how this class can vary depending on body placement, duration of use, and increased risk to the patient.

该规定还带来了 22 条规则，以帮助制造商正确分类他们的设备。这些规则根据设备的应用、身体放置位置、使用时长和对患者的增加风险来确定设备的类别。

For instance, catheters and intraocular lenses are considered medical device class II since both are invasive. However, catheters are intended for transient or short-term use, putting them in the IIa class.

例如，导管和人工晶体都被视为医疗器械二类，因为两者都是侵入性的。然而，导管是用于短暂或短期使用的，因此被归类为 IIa 类。

But intraocular lenses have long-term use. Therefore, they are considered at higher risk, being marked as class IIb.

但是人工晶体具有长期使用的特点。因此，它们被认为具有更高的风险，被标记为 IIb 类。

2. Designate a Person Responsible for Regulatory Compliance 指定一名负责监管合规的人员

Medical device manufacturers must have at least one person responsible for regulatory compliance within the company. And this person needs to have expertise in the field of medical devices.

医疗器械制造商必须在公司内至少有一名负责监管合规的人员。而且这个人需要在医疗器械领域具备专业知识。

If you are still a small organization, there is no need to have personnel on-site. But this person has to be available permanently and continuously.

如果您的组织仍然很小，就没有必要在现场配备人员。但是这个人必须永久和持续地可用。

3. Implement a Quality and Risk Management System 实施质量和风险管理系统

The MDR requires manufacturers to have quality and risk management systems.

MDR 要求制造商拥有质量和风险管理系统。

That is why medical device companies chose to comply with ISO 13485:2016 because it is presumed to be in conformity with MDR requirements regarding QMS.

这就是为什么医疗器械公司选择遵守 ISO 13485:2016，因为它被认为符合 MDR 对 QMS 的要求。

These days, leading companies are choosing to implement electronic QMS over the traditional paper-based or hybrid system. Digital systems simplify QMS documentation and streamline audits.

如今，领先的公司选择实施电子 QMS 而不是传统的纸质或混合系统。数字系统简化了 QMS 文档，并简化了审计流程。

A QMS software solution like SimplerQMS can streamline and automate many aspects of quality management, from document control and change management to training, audits, suppliers, non-conformances, CAPAs, and more.

像 SimplerQMS 这样的 QMS 软件解决方案可以简化和自动化质量管理的许多方面，包括文件控制和变更管理、培训、审计、供应商、不符合项、CAPA 等等。

4. Prepare Technical Documentation 准备技术文档

Technical documentation, also known as medical device technical files, contains detailed information regarding your medical device lifecycle and is a requirement of MDR.

技术文档，也被称为医疗器械技术文件，包含有关您的医疗器械生命周期的详细信息，并且是符合 MDR 的要求。

A crucial process is the Design Control or Design Dossier, which contains information about a device’s physical characteristics and construction. It must prove that the medical device was designed in the best way possible to minimize the risk of injuries or accidents.

一个关键的过程是设计控制或设计档案，其中包含有关设备的物理特性和结构的信息。它必须证明医疗器械是以最佳方式设计的，以最大程度地减少受伤或事故的风险。

To achieve compliance, all documentation needs to be well organized, readily accessible, and easy to understand.

为了达到合规要求，所有文档都需要组织良好，易于访问和理解。

It includes, but is not limited to:

它包括但不限于：

• Device description and specification 设备描述和规格
• Description of the accessories and variations 配件和变种的描述
• Reference to previous and similar generations 参考以前和类似的一代
• Instructions in the country’s language in which the device will be sold 以设备销售的国家语言的说明
• Design and manufacturing information 符合一般安全和性能要求的演示一致性的信息
• Information for the demonstration of conformity with the general safety and performance requirements 设计和制造信息
• Risk analysis documents, such as design risk, production risk, biological risk, and so on 风险分析文件，如设计风险、生产风险、生物风险等
• Product verification and validation 产品验证和验证
• Post-market surveillance plan
• 市场后监测计划

These documents must be retained for a period of 10 to 15 years, depending on the device classification and customer requirements.

这些文件必须保留 10 至 15 年，具体取决于设备分类和客户要求。

SimplerQMS helps with the compilation of Technical Documentation. Using our robust design controls and cloud-based storage, medical device manufacturers have the support to achieve compliance with the MDR.

SimplerQMS 帮助编制技术文档。使用我们强大的设计控制和基于云的存储，医疗器械制造商可以获得支持，以达到符合 MDR 的要求。

5. Implement Supplier Management System 实现供应商管理系统

MDR requires medical device companies to have supplier management. Suppliers must be audited to ensure compliance with requirements and conformity.

MDR 要求医疗器械公司具备供应商管理。必须对供应商进行审计，以确保符合要求和一致性。

It is helpful to create a list of approved suppliers based on predetermined criteria to ensure only qualified suppliers provide products and services.

根据预先确定的标准，创建一个批准供应商的列表是有帮助的，以确保只有合格的供应商提供产品和服务。

In accordance with the MDR, medical device manufacturers’ suppliers can, if needed, be audited by external organizations, known as Notified Bodies. The audits can be announced or unannounced.

根据 MDR 的规定，医疗器械制造商的供应商可以在需要时由外部机构进行审计，这些机构被称为通知机构。审计可以是预先通知的或未经通知的。

The supplier audit can be simplified if they have already been audited by a Notified Body or have a certified QMS.

如果供应商已经通过通知机构的审计或拥有认证的质量管理体系，供应商审计可以简化。

SimplerQMS solution assists you with your supplier management processes by providing a centralized repository for all your supplier information, maintaining an Approved Supplier List (ASL), creating an audit plan, as well as other reoccurring supplier-related tasks, and receiving notifications when scheduled tasks are due.

简化的 QMS 解决方案通过为所有供应商信息提供集中存储库，维护批准供应商列表（ASL），创建审计计划以及其他重复出现的供应商相关任务，并在计划任务到期时接收通知，帮助您管理供应商流程。

6. Conduct a Clinical Evaluation 进行临床评估

Manufacturers must conduct a clinical evaluation to demonstrate conformity with safety and performance requirements.

制造商必须进行临床评估，以证明符合安全和性能要求。

Practically, it means a plan to collect and analyze clinical data from relevant scientific literature and clinical investigations involving the specific medical device or an equivalent product.

实际上，这意味着制定一个计划，收集和分析与特定医疗器械或等效产品相关的科学文献和临床研究的临床数据。

Manufacturers must also consult an expert panel for devices in classes IIb and III.

制造商还必须就 IIb 类和 III 类设备咨询专家小组。

7. Assign a European-Authorized Representative (if Applicable) 指定欧洲授权代表（如适用）

If a medical device manufacturer is not based on the EEA, they will need to appoint an authorized representative inside the member countries.

如果医疗器械制造商不在欧洲经济区内，他们将需要在成员国内指定一位授权代表。

The authorized representative is responsible for actions such as:

授权代表负责以下行动：

• Verifying the technical documentation 验证技术文件
• Informing the manufacturer about complaints 通知制造商有关投诉的情况
• Registering a physical place for the Notified Body to receive samples of the device for inspection 注册一个物理场所，以供通知机构接收设备样品进行检查

Imagine a medical device manufacturer from Canada who wishes to enter the EU market to sell pacemakers. To do so, they will need a European representative to address their documentation inside Europe.

想象一下，一家来自加拿大的医疗器械制造商希望进入欧盟市场销售心脏起搏器。为了做到这一点，他们需要一位欧洲代表来处理他们在欧洲的文件。

8. Obtain Certification by a Notified Body 通过通知机构获得认证

Notified Body is an independent organization designed to assess the conformity of specific products before their placement on the market.

通知机构是一个独立的组织，旨在评估特定产品在上市前的符合性。

Regarding medical devices, they are responsible for auditing and certifying manufacturers concerning the conformity of devices with MDR.

关于医疗器械，他们负责审核和认证制造商，确保器械符合 MDR 的要求。

A list of valid Notified Bodies can be found in the New Approach Notified and Designated Organizations (NANDO) system.

有效通知机构的列表可以在新方法通知和指定组织（NANDO）系统 EUROPA – European Commission – Growth – Regulatory policy - SMCS 中找到。

A Notified Body does not need to assess manufacturers of class I non-sterile and no measuring devices. In these cases, companies can issue a self-declaration of conformity.

通知机构不需要评估 I 类非无菌和无测量设备的制造商。在这些情况下，公司可以自行声明符合性。

For higher classes devices, this certification is mandatory, specific for each procedure, and has a maximum validity of five years.

对于更高级别器械，此认证是强制性的，针对每个程序具体规定，并且最长有效期为五年。

The Notified Body will then audit the manufacturer’s QMS and technical documentation to verify conformity with the MDR. This is a critical part of the process.

指定机构将审核制造商的质量管理体系和技术文件，以验证其符合医疗器械监管法规。这是流程的关键部分。

Manufacturers will receive a certification from the Notified Body once the audit is complete. In the case of audit findings, those must be corrected and closed before another audit round is conducted.

制造商在审核完成后将收到指定机构颁发的认证。在审核发现问题的情况下，必须在进行另一轮审核之前进行纠正和关闭。

Audits and assessments occur periodically every year to ensure companies are applying the approved QMS and post-market surveillance plan.

每年定期进行审核和评估，以确保公司应用批准的质量管理体系和售后监测计划。

9. Prepare a Declaration of Conformity 准备符合性声明

After being certificated by a Notified Body, manufacturers must draw up a Declaration of Conformity, assuming responsibility that the requirements specified in MDR have been fulfilled.

在获得认证机构的认证后，制造商必须制定一份符合性声明，承担满足 MDR 中规定的要求的责任。

10. Register Your Device Under a Unique Device Identifier 在唯一设备标识符下注册您的设备

To facilitate the traceability of medical devices, a unique device identifier (UDI) needs to be assigned individually to specific device models.

为了方便医疗设备的可追溯性，需要为特定设备型号分配一个唯一设备标识符（UDI）。

The UDI is a unique number or alphanumeric code stored in the European Database on Medical Devices (EUDAMED), where crucial information about the device can be found.

UDI 是一个唯一的数字或字母代码，存储在欧洲医疗器械数据库（EUDAMED）中，可以找到有关设备的重要信息。

Affixing the UDI is an additional requirement. And it does not replace the CE marking or other labeling requirements.

附着 UDI 是一个额外的要求。它不取代 CE 标志或其他标签要求。

11. Affix a CE Marking to the Medical Device 将 CE 标志附在医疗器械上

After being approved by national authorities and certified by the Notified Body, manufacturers can place the CE marking on their medical devices.

在经过国家机构的批准并由通知机构认证后，制造商可以在其医疗器械上放置 CE 标志。

The CE marking must be affixed to the device itself, in the packaging, and on any instructions for use.

CE 标志必须附在设备本身、包装上以及任何使用说明上。

It is crucial for the CE marking to be visible, legible, and made with a material that cannot be washed away.

CE 标志的可见性、清晰度和不能被洗掉的材料制作非常重要。

For medical devices class II and III, the four-digit number of the Notified Body also needs to be printed alongside the CE marking.

对于 II 类和 III 类医疗器械，通知机构的四位数也需要与 CE 标志一起打印。

12. Maintain a Post-Market Surveillance 维持市场监测

Before obtaining a CE marking and placing a medical device into the EAA market, manufacturers need to demonstrate that a post-market surveillance system is already in place to address questions on safety and effectiveness.

在获得 CE 标志并将医疗器械投放到欧洲经济区市场之前，制造商需要证明已经建立了一个市场监测系统，以解决安全性和有效性方面的问题。

Medical device companies must collect data regarding their marketed devices through post-market surveillance, vigilance, and market surveillance plans.

医疗器械公司必须通过市场监测、警惕性和市场监测计划收集有关其市场销售的设备的数据。

This feedback involves continuously evaluating the patient’s experience with the medical device and the product life cycle.

这种反馈涉及持续评估患者对医疗器械和产品生命周期的体验。

Requirements of manufacturers are:

制造商的要求是：

• Follow-up complaints, adverse events, and non-conformity cases 跟进投诉、不良事件和不符合情况
• Update safety reports periodically 定期更新安全报告
• Perform internal audits and supplier audits routinely 定期进行内部审计和供应商审计
• Keep technical documentation, databases, and registers updated 保持技术文件、数据库和注册表的更新

This surveillance ensures proactive action to collect and review device quality and safety information from real-world evidence. Therefore, manufacturers can better address customer complaints, identify risks, and implement recalls and other market actions.

这种监视确保了积极采取行动，从实际证据中收集和审查设备质量和安全信息。因此，制造商可以更好地处理客户投诉，识别风险，并实施召回和其他市场行动。

For more details, you can also read your article about Post-Market Surveillance (PMS) for medical devices.

有关更多详细信息，您还可以阅读有关医疗设备后市场监测（PMS）的文章。

A smart way to handle your device PMS is by implementing an eQMS with features such as built-in forms for handling non-conformance and complaint events that allow for automated linking and processing of Corrective and Preventive Actions (CAPAs).

处理器械 PMS 的聪明方法是通过实施具有内置表单的 eQMS 来处理不符合和投诉事件，从而实现自动链接和处理纠正和预防措施（CAPAs）。

SimplerQMS software offers all of that and more. Medical device companies can easily link any PMS issue to a specific device, component batch, customer complaint, and equipment failure.

SimplerQMS 软件提供所有这些以及更多。医疗设备公司可以轻松将任何 PMS 问题与特定设备、组件批次、客户投诉和设备故障联系起来。

In Great Britain (England, Scotland, and Wales), the CE marking is still valid until June 2023 for manufacturers who wish to sell their medical devices in this market.

在英国（包括英格兰、苏格兰和威尔士），CE 标志仍然有效，直到 2023 年 6 月，对于希望在该市场销售其医疗设备的制造商。

Afterward, the CE marking will no longer be accepted, and a UK Conformity Assessed (UKCA) marking will be required.

此后，将不再接受 CE 标志，需要使用英国合格评定（UKCA）标志。

For instance, after June 2023, a medical device manufacturer from Germany that wants to place their device in the Great Britain market will need to obtain a UKCA marking.

例如，2023 年 6 月之后，来自德国的医疗设备制造商如果想将其设备放置在英国市场上，就需要获得 UKCA 标志。

And the opposite also applies. This means a company from England must have a CE marking to sell into the EEA market.

反之亦然。这意味着英国的公司必须具有 CE 标志才能在欧洲经济区市场上销售。

Both organizations, in this example, must appoint an authorized representative inside the market they wish to operate.

在这个例子中，两个组织都必须在他们希望经营的市场内指定一位授权代表。

SimplerQMS Streamlines CE Marking Process 简化 QMS 简化 CE 标志流程

There are many steps to obtain the CE marking, and there is even more documentation for each step.

获得 CE 标志有许多步骤，每个步骤都有更多的文件。

Managing these documents is challenging enough, and more so with a paper-based QMS. Even with a hybrid system, important documents can be lost, filled in wrongly, and taken too long to access during an audit.

管理这些文件已经足够具有挑战性，而使用基于纸张的 QMS 则更加如此。即使使用混合系统，重要文件也可能丢失，填写错误，并且在审核期间访问时间过长。

Storage is also an issue when using physical files. Keeping a significant number of documents for up to 15 years or even more can be troublesome space-wise.

使用实体文件时，存储也是一个问题。保留大量文件长达 15 年甚至更长时间可能会在空间上带来麻烦。

Here are some exciting features medical device eQMS, such as SimplerQMS, offers:

以下是一些医疗设备 eQMS 的令人兴奋的功能，例如 SimplerQMS：

• QMS software facilitates the process of compiling technical documentation by keeping all relevant information in one location and making it easy to share and access. QMS 软件通过将所有相关信息保存在一个位置并使其易于共享和访问，简化了技术文件编制过程。
• Allows the development of documents using best-practice ISO 13485:2016 templates and forms. 使用最佳实践 ISO 13485:2016 模板和表格开发文件。
• Automates various documentation processes, freeing your team to focus on more critical tasks and saving time while ensuring consistency and accuracy of information. 自动化各种文件处理过程，使您的团队能够专注于更重要的任务，节省时间，同时确保信息的一致性和准确性。
• Simplifies the auditing process, as the system ensures accurate and readily available documents in a cloud storage system. 帮助维护您的 CE 合规性标志，因为它已经具备了后市场监测计划和处理投诉和不良事件的流程。
• Helps maintain your CE marking of conformity, as it already has post-market surveillance plans and processes to deal with complaints and adverse events. 简化审计过程，因为系统确保在云存储系统中准确可用的文件。
• Helps you keep the documentation organized for as long as required for your medical devices without compromising physical space. 帮助您在不损害物理空间的情况下保持所需时间的医疗设备文档的组织。

With the MDR in place, transitioning can be much easier using an eQMS solution.

有了 MDR，使用 eQMS 解决方案进行过渡会更容易。

SimplerQMS provides a cloud-based quality management software built to help medical device companies comply with Life Science requirements and obtain their CE marking.

SimplerQMS 提供基于云的质量管理软件，旨在帮助医疗器械公司符合生命科学要求并获得 CE 标志。

The software solution automates and facilitates your quality management processes, saving valuable time and resources while helping you ensure compliance.

该软件解决方案自动化和促进您的质量管理流程，节省宝贵的时间和资源，同时帮助您确保合规性。

We provide a fully validated system according to GAMP 5 and conduct continuous re-validation, so there is no need to spend time and money on validation yourself. SimplerQMS takes full responsibility for our solution and provides audit assistance related to eQMS software.

我们提供完全符合 GAMP 5 的经过验证的系统，并进行持续再验证，因此无需花费时间和金钱进行自我验证。SimplerQMS 对我们的解决方案负有全部责任，并提供与 eQMS 软件相关的审计协助。

If you are interested in implementing an eQMS solution in your company, go ahead and download our eQMS Business Case template. With this, you can calculate the real economic benefit and time advantages of an eQMS versus a manual or paper-based system!

如果您有兴趣在公司中实施 eQMS 解决方案，请继续下载我们的 eQMS 商业案例模板。通过这个模板，您可以计算 eQMS 与手动或纸质系统相比的真实经济效益和时间优势！

Frequently Asked Questions About CE Marking 关于 CE 标志的常见问题

Is CE Marking the Same as FDA Approval? CE 标志与 FDA 批准是否相同？

European CE marking and United States FDA approval both have the same goal — to assess the safety and efficacy of medical devices. However, they are only valid in the markets on which they are based.

欧洲 CE 标志和美国 FDA 批准都有相同的目标 — 评估医疗器械的安全性和有效性。然而，它们只在其基础市场上有效。

Which Countries Require CE Marking for Medical Devices? 哪些国家要求医疗器械进行 CE 标志？

CE marking is required in the countries of the European Economic Area, which encloses the EU countries as well as Iceland, Norway, Lichtenstein, and Switzerland.

CE 标志在欧洲经济区的国家是必需的，该区域包括欧盟国家以及冰岛、挪威、列支敦士登和瑞士。

How Long Does CE Marking Approval Take? CE 标志批准需要多长时间？

CE marking approval times are variable. It depends on the class and complexity of the device, as well as whether the manufacturer has a QMS in place and is already ISO 13485:2016 certified. Usually, obtaining a CE marking can take 16 to 18 months from beginning to end.

CE 标志批准的时间是可变的。它取决于设备的等级和复杂性，以及制造商是否已经建立了质量管理体系并获得了 ISO 13485:2016 认证。通常，获得 CE 标志可能需要 16 到 18 个月的时间。

How Long Is a CE Marking Valid? CE 标志的有效期有多长？

CE marking validity will be determined by the Notified Body and depends on the medical device classification, but it cannot exceed five years. After that, the device needs to be re-certificated.

CE 标志的有效期将由通知机构确定，并取决于医疗器械的分类，但不能超过五年。之后，设备需要重新获得认证。

For instance, a class IIa device can receive a certificate valid for just three years.

例如，IIa 类设备可以获得有效期为三年的证书。

Moreover, annual surveillance audits are conducted between certifications.

此外，每年都会进行认证之间的监督审计。

Can I CE Mark My Own Medical Device Product? 我可以为自己的医疗器械产品打上 CE 标志吗？

Medical devices class I non-sterile and no measuring types can be self-declared. However, higher classes need to be assessed by Notified Bodies to receive a CE marking.

非无菌和无测量类型的 I 类医疗器械可以自行声明。然而，更高级别的器械需要由通知机构进行评估，以获得 CE 标志。

How Many Notified Bodies Are There For the CE Marking? CE 标志的通知机构有多少个？

According to the NANDO database, in the year 2022, 34 Notified Bodies are authorized for MDR and 7 for IVDR**.**

根据 NANDO 数据库，在 2022 年，有 34 个通知机构获得了 MDR 的授权，7 个通知机构获得了 IVDR 的授权。

Is CE Marking the Same As UKCA Marking? CE 标志和 UKCA 标志是一样的吗？

Both CE marking and UKCA marking share the same goal – to ensure the safety and quality of products. But CE marking is specific to the EEA market, and UKCA marking is exclusive for products placed in Great Britain (England, Scotland, and Wales).

CE 标志和 UKCA 标志有着相同的目标-确保产品的安全和质量。但是 CE 标志专门针对欧洲经济区市场，而 UKCA 标志专门针对在大不列颠（英格兰、苏格兰和威尔士）销售的产品。

Conclusion 总结

Obtaining a CE marking is a mandatory step for medical device manufacturers that intend to sell their products on the EEA market.

对于打算在欧洲经济区市场销售其产品的医疗设备制造商来说，获得 CE 标志是一个强制性的步骤。

This can be a somewhat complex process involving a high volume of technical documents that must be accurate and in compliance with standards and regulations.

这可能是一个相对复杂的过程，涉及大量必须准确并符合标准和法规的技术文件。

Thus, having QMS software in place is a smart decision to manage all information about medical devices successfully.

因此，拥有 QMS 软件是一个明智的决策，可以成功管理有关医疗设备的所有信息。

SimplerQMS provides a QMS software solution that supports compliance with MDR and ISO 13485:2016 and helps medical device organizations of all sizes streamline their CE marking process.

SimplerQMS 提供了一种 QMS 软件解决方案，支持符合 MDR 和 ISO 13485:2016，并帮助各种规模的医疗设备组织简化其 CE 标志过程。

If you are interested in streamlining quality management processes and making compliance simpler for your business, book a demo and talk to our experts today!

如果您有兴趣简化质量管理流程并使合规性对您的业务更简单，请预约演示并与我们的专家交流！

References 参考文献

• CE Marking for Medical Devices [Step-by-Step Guide]